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EC number: 229-222-8
CAS number: 6440-58-0
It can be concluded that short-term toxicity testing of terrestrial plants is not required based on the unlikely exposure of plants to the DMDMH product or its degradation product (DMH), rapid biodegradability in the environment and the additional evidence of no toxicity observed in plants based on long-term toxicity testing of the breakdown product.
Annex IX of Regulation (EC) No 1907/2006, it is laid down that
short-term toxicity to terrestrial plants shall be proposed by the
registrant if the chemical safety assessment indicates the need to
investigate the effects of the substance and/or relevant degradation
products on terrestrial plants. Column
2 of Annex IX states that studies do not need to be conducted if direct
and indirect exposure of the soil compartment is unlikely.
product is not supposed to be directly applied to soil and indirect
exposure of terrestrial plants is unlikely since the test substance and
its degradation product (DMH) are readily biodegraded in the aquatic
environment and STP processes. Therefore no short-term tests on
terrestrial plants are required in accordance with Annex IX of
Regulation (EC) No 1907/2006.
information, there are no reliable toxicity data for plants relating to
reliable toxicity data for terrestrial plants are available for DMH, the
hydrolysis product of DMDMH. DMDMH
readily undergoes hydrolysis to DMH and therefore data are provided for
both substances when available. In the case of long-term testing, the
data on DMH are considered more relevant for environmental fate and
ecotoxicology and are considered in this dossier.
(2007) conducted a reliable (Klimisch 1) GLP compliant study following
OECD 208 methods. Soybean
(Glycine max), cucumber (Cucumis sativa) and oat (Avena sativa) were
exposed to concentrations of DMH,(application
rate of 40, 100, 160, 400 and 1000 mg/kg) in a test for 21 days to
measure seedling emergence and growth. The
21-day EC50, based on emergence, for the oat and soybean test species
was >1000 mg/kg and 990 mg/kg for the cucumber. The
EC50, based on growth, for all three species is 1000mg/kg. The
21-day NOECs, based on emergence, for the oat, soybean and cucumber were
100, 400, and 400 mg/kg, respectively. The
21-day NOECs, based on growth, for the oat, soybean and cucumber were
400, 160, and 1000 mg/kg, respectively.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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